Last data update: Apr 22, 2024. (Total: 46599 publications since 2009)
Records 1-30 (of 55 Records) |
Query Trace: Workowski K[original query] |
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Syphilis complicating pregnancy and congenital syphilis
Stafford IA , Workowski KA , Bachmann LH . N Engl J Med 2024 390 (3) 242-253 Congenital syphilis, first described by Gaspar Torella in 1497, results primarily from the transplacental passage of Treponema pallidum and continues to cause major negative consequences worldwide.1 After a steady decline in U.S. cases of primary and secondary syphilis after 1990, which led to hopes of its elimination, rates hit a nadir in 2001. Unfortunately, the rates have subsequently increased among men and women of reproductive age, as well as infants, and in 2021, the rate of congenital syphilis in the United States was the highest it has been in nearly 30 years.2 |
Selective whole genome amplification as a tool to enrich specimens with low Treponema pallidum genomic DNA copies for whole genome sequencing (preprint)
Thurlow CM , Joseph SJ , Ganova-Raeva L , Katz SS , Pereira L , Chen C , Debra A , Vilfort K , Workowski K , Cohen SE , Reno H , Sun Y , Burroughs M , Sheth M , Chi KH , Danavall D , Philip SS , Cao W , Kersh EN , Pillay A . bioRxiv 2021 10 Downstream next generation sequencing (NGS) of the syphilis spirochete Treponema pallidum subspecies pallidum (T. pallidum) is hindered by low bacterial loads and the overwhelming presence of background metagenomic DNA in clinical specimens. In this study, we investigated selective whole genome amplification (SWGA) utilizing multiple displacement amplification (MDA) in conjunction with custom oligonucleotides with an increased specificity for the T. pallidum genome, and the capture and removal of CpG-methylated host DNA using the NEBNext Microbiome DNA Enrichment Kit followed by MDA with the REPLI-g Single Cell Kit as enrichment methods to improve the yields of T. pallidum DNA in isolates and lesion specimens from syphilis patients. Sequencing was performed using the Illumina MiSeq v2 500 cycle or NovaSeq 6000 SP platform. These two enrichment methods led to 93-98% genome coverage at 5 reads/site in 5 clinical specimens from the United States and rabbit propagated isolates, containing >14 T. pallidum genomic copies/ul of sample for SWGA and >129 genomic copies/ul for CpG methylation capture with MDA. Variant analysis using sequencing data derived from SWGA-enriched specimens, showed that all 5 clinical strains had the A2058G mutation associated with azithromycin resistance. SWGA is a robust method that allows direct whole genome sequencing (WGS) of specimens containing very low numbers of T. pallidum, which have been challenging until now. Copyright The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license. |
Sexually transmitted infection/human immunodeficiency virus, pregnancy, and mental health-related services provided during visits with sexual assault and abuse diagnosis for US medicaid beneficiaries, 2019
Tao G , Li J , Johns M , Patel CG , Workowski K . Sex Transm Dis 2023 50 (7) 425-431 BACKGROUND: Centers for Disease Control recommends that the decision to provide sexually transmitted infection (STI)/human immunodeficiency virus (HIV) testing and presumptive treatment to patients who report sexual assault and abuse (SAA) be made on an individual basis. METHODS: The 2019 Centers for Medicare & Medicaid Services national Medicaid data set was used. The SAA visits were identified by International Classification of Diseases 10th Revision Clinical Modification (O9A4 for pregnancy-related sexual abuse, T74.2 for confirmed sexual abuse, and Z04.4 for alleged rape). The initial SAA visit was defined as the patient's first SAA-related visit. Medical services were identified by International Classification of Diseases 10th Revision Clinical Modification codes, Current Procedural Terminology codes, and National Drug Code codes. RESULTS: Of 55,113 patients at their initial SAA visits, 86.2% were female; 63.4% aged ≥13 years; 59.2% visited emergency department (ED); all STI/HIV tests were provided in ≤20% of visits; presumptive gonorrhea and chlamydia treatment was provided in 9.7% and 3.4% of visits, respectively; pregnancy test was provided in 15.7% of visits and contraception services was provided in 9.4% of visits; and diagnosed anxiety was provided in 6.4% of visits. Patients who visited ED were less likely to have STI testing and anxiety than those visited non-ED facilities, but more likely to receive presumptive treatment for gonorrhea, testing for pregnancy, and contraceptive services. About 14.2% of patients had follow-up SAA visits within 60 days after the initial SAA visit. Of 7821 patients with the follow-up SAA visits within 60 days, most medical services provided were chlamydia testing (13.8%), gonorrhea testing (13.5%), syphilis testing (12.8%), HIV testing (14.0%); diagnosed anxiety (15.0%), and posttraumatic stress disorder (9.8%). CONCLUSIONS: Current medical services during SAA visits for Medicaid patients are described in this evaluation. More collaboration with staff who handle SAA will improve SAA-related medical services. |
Selective Whole-Genome Amplification as a Tool to Enrich Specimens with Low Treponema pallidum Genomic DNA Copies for Whole-Genome Sequencing.
Thurlow CM , Joseph SJ , Ganova-Raeva L , Katz SS , Pereira L , Chen C , Debra A , Vilfort K , Workowski K , Cohen SE , Reno H , Sun Y , Burroughs M , Sheth M , Chi KH , Danavall D , Philip SS , Cao W , Kersh EN , Pillay A . mSphere 2022 7 (3) e0000922 Downstream next-generation sequencing (NGS) of the syphilis spirochete Treponema pallidum subspecies pallidum (T. pallidum) is hindered by low bacterial loads and the overwhelming presence of background metagenomic DNA in clinical specimens. In this study, we investigated selective whole-genome amplification (SWGA) utilizing multiple displacement amplification (MDA) in conjunction with custom oligonucleotides with an increased specificity for the T. pallidum genome and the capture and removal of 5'-C-phosphate-G-3' (CpG) methylated host DNA using the NEBNext Microbiome DNA enrichment kit followed by MDA with the REPLI-g single cell kit as enrichment methods to improve the yields of T. pallidum DNA in isolates and lesion specimens from syphilis patients. Sequencing was performed using the Illumina MiSeq v2 500 cycle or NovaSeq 6000 SP platform. These two enrichment methods led to 93 to 98% genome coverage at 5 reads/site in 5 clinical specimens from the United States and rabbit-propagated isolates, containing >14 T. pallidum genomic copies/μL of sample for SWGA and >129 genomic copies/μL for CpG methylation capture with MDA. Variant analysis using sequencing data derived from SWGA-enriched specimens showed that all 5 clinical strains had the A2058G mutation associated with azithromycin resistance. SWGA is a robust method that allows direct whole-genome sequencing (WGS) of specimens containing very low numbers of T. pallidum, which has been challenging until now. IMPORTANCE Syphilis is a sexually transmitted, disseminated acute and chronic infection caused by the bacterial pathogen Treponema pallidum subspecies pallidum. Primary syphilis typically presents as single or multiple mucocutaneous lesions and, if left untreated, can progress through multiple stages with various clinical manifestations. Molecular studies often rely on direct amplification of DNA sequences from clinical specimens; however, this can be impacted by inadequate samples due to disease progression or timing of patients seeking clinical care. While genotyping has provided important data on circulating strains over the past 2 decades, WGS data are needed to better understand strain diversity, perform evolutionary tracing, and monitor antimicrobial resistance markers. The significance of our research is the development of an SWGA DNA enrichment method that expands the range of clinical specimens that can be directly sequenced to include samples with low numbers of T. pallidum. |
Diagnosis and management of trichomonas vaginalis: Summary of evidence reviewed for the 2021 Centers for Disease Control and Prevention Sexually Transmitted Infections Treatment Guidelines
Kissinger PJ , Gaydos CA , Sea AC , ScottMcClelland R , Soper D , Secor WE , Legendre D , Workowski KA , Muzny CA . Clin Infect Dis 2022 74 S152-s161 Trichomonas vaginalis is likely the most prevalent nonviral sexually transmitted infection, affecting an estimated 3.7 million women and men in the United States. Health disparities are prominent in the epidemiology of trichomoniasis, as African Americans are >4 times more likely to be infected than persons of other races. Since publication of the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines, additional data have bolstered the importance of T. vaginalis infection sequelae in women, including increased risk of human immunodeficiency virus (HIV) acquisition, cervical cancer, preterm birth, and other adverse pregnancy outcomes. Less is known about the clinical significance of infection in men. Newly available diagnostic methods, including point-of-care assays and multiple nucleic acid amplification tests, can be performed on a variety of genital specimens in women and men, including urine, allowing more accurate and convenient testing and screening of those at risk for infection. Repeat and persistent infections are common in women; thus, rescreening at 3 months after treatment is recommended. In vitro antibiotic resistance to 5-nitroimidazole in T. vaginalis remains low (4.3%) but should be monitored. High rates of T. vaginalis among sexual partners of infected persons suggest a role for expedited partner treatment. A randomized controlled trial in HIV-uninfected women demonstrated that multidose metronidazole 500 mg twice daily for 7 days reduced the proportion of women with Trichomonas infection at 1 month test of cure compared with women receiving single-dose therapy (2 g). The 2-g single-dose oral metronidazole regimen remains the preferred treatment in men. |
Enteric infections in men who have sex with men
McNeil CJ , Kirkcaldy RD , Workowski K . Clin Infect Dis 2022 74 S169-s178 BACKGROUND: Enteric pathogens are often associated with exposure to food, water, animals, and feces from infected individuals. However, in sexual networks of men who have sex with men (MSM), transmission of enteric pathogens may occur during direct or indirect oral-anal contact. METHODS: We performed a scoping review of the literature for studies prior to July 2019 with key terms for gastrointestinal syndromes ("proctitis," "enteritis," "proctocolitis"), enteric pathogens or sexually transmitted infections (STIs), and outbreaks using multiple electronic databases. RESULTS: We identified 5861 records through database searches, bibliography reviews, and keyword searches, of which 117 references were included in the pathogen-specific reviews. CONCLUSIONS: The strength of observational data describing enteric pathogens in MSM and possible sexual transmission of enteric pathogens varies by pathogen; however, a robust body of literature describes the sexual transmission of Campylobacter, Giardia lamblia, and Shigella (particularly antimicrobial-resistant strains) in sexual networks of MSM. Providers are encouraged to consider enteritis or proctocolitis in MSM as possibly having been sexually transmitted and encourage targeted STI testing. Risk/harm reduction and prevention messages should also be incorporated, though there is an acknowledged paucity of evidence with regards to effective strategies. Further research is needed to understand the transmission and prevention of enteric pathogens in MSM. |
Diagnosis and management of bacterial vaginosis: Summary of Evidence Reviewed for the 2021 Centers for Disease Control and Prevention Sexually Transmitted Infections Treatment Guidelines
Muzny CA , Balkus J , Mitchell C , Sobel JD , Workowski K , Marrazzo J , Schwebke JR . Clin Infect Dis 2022 74 S144-s151 In preparation for the 2021 Centers for Disease Control and Prevention (CDC) sexually transmitted infections (STIs) treatment guidelines, the CDC convened an advisory group in 2019 to examine recent literature addressing updates in the epidemiology, diagnosis, and management of STIs. This article summarizes recent data in each of these key topic areas as they pertain to bacterial vaginosis (BV), the most common cause of vaginal discharge. The evidence reviewed primarily focused on updates in the global epidemiology of BV, risk factors for BV, data supportive of sexual transmission of BV-associated bacteria, BV molecular diagnostic tests, and novel treatment regimens. Additionally, recent literature on alcohol abstinence in the setting of 5-nitroimidazole use was reviewed. |
Centers for Disease Control and Prevention's Sexually Transmitted Diseases Infection Guidelines
Workowski KA , Bachmann LH . Clin Infect Dis 2022 74 S89-s94 Sexually transmitted infections (STIs) constitute an epidemic of tremendous magnitude, with an estimated 27 million persons acquiring a new STI in 2018 at a cost of $16 billion [1, 2]. Reported disease rates underestimate the true burden of infection because the majority of STIs are asymptomatic and underreported [3]. STIs have far-reaching public health consequences on the sexual and reproductive health of individuals, as well as long-term healthcare costs to the community [2]. Due to the dramatic increase in reportable STI rates with resultant reproductive health consequences, an STI National Strategic Plan (https://www.hhs.gov/sites/default/files/STI-National-Strategic-Plan-2021-2025.pdf) was developed with actionable goals, objectives, and strategies for prevention that focus on 4 of the STIs with the highest morbidity rates (chlamydia, gonorrhea, syphilis, and human papillomavirus), though most of the components of the plan are applicable to other STIs (herpes simplex virus, trichomoniasis, Mycoplasma genitalium). |
Surveillance for disseminated gonococcal infections, Active Bacterial Core surveillance (ABCs) - United States, 2015-2019
Weston EJ , Heidenga BL , Farley MM , Tunali A , D'Angelo MT , Moore A , Workowski K , Raphael BH , Weinstock H , Torrone E . Clin Infect Dis 2022 75 (6) 953-958 BACKGROUND: Disseminated gonococcal infections (DGI) are thought to be uncommon; surveillance is limited and case reports are analyzed retrospectively or in case clusters. We describe the population-level burden of culture-confirmed DGI through the Active Bacterial Core surveillance (ABCs) system. METHODS: During 2015-2016, retrospective surveillance was conducted among residents in two ABCs areas and prospectively in three ABCs areas during 2017-2019. A DGI case was defined as isolation of Neisseria gonorrhoeae (Ng) from a normally sterile site. A case report form was completed for each case and antimicrobial susceptibility testing (AST) was performed on available isolates. RESULTS: During 2015-2019, 77 DGI cases were identified (~a rate of 0.13 cases per 100,000 population) and accounted for 0.06% of all reported gonorrhea cases in the three surveillance areas. Most DGI cases were male (64%), non-Hispanic Black (68%), and ranged from 16-67 years; blood (55%) and joint (40%) were the most common sterile sites. Among 29 isolates with AST results during 2017-2019, all were susceptible to ceftriaxone. CONCLUSIONS: DGI is an infrequent complication of Ng; since Ng can quickly develop antimicrobial resistance, continued DGI surveillance, including monitoring trends in antimicrobial susceptibility, could help inform DGI treatment recommendations. |
Sexually Transmitted Infections Treatment Guidelines, 2021
Workowski KA , Bachmann LH , Chan PA , Johnston CM , Muzny CA , Park I , Reno H , Zenilman JM , Bolan GA . MMWR Recomm Rep 2021 70 (4) 1-187 These guidelines for the treatment of persons who have or are at risk for sexually transmitted infections (STIs) were updated by CDC after consultation with professionals knowledgeable in the field of STIs who met in Atlanta, Georgia, June 11-14, 2019. The information in this report updates the 2015 guidelines. These guidelines discuss 1) updated recommendations for treatment of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis; 2) addition of metronidazole to the recommended treatment regimen for pelvic inflammatory disease; 3) alternative treatment options for bacterial vaginosis; 4) management of Mycoplasma genitalium; 5) human papillomavirus vaccine recommendations and counseling messages; 6) expanded risk factors for syphilis testing among pregnant women; 7) one-time testing for hepatitis C infection; 8) evaluation of men who have sex with men after sexual assault; and 9) two-step testing for serologic diagnosis of genital herpes simplex virus. Physicians and other health care providers can use these guidelines to assist in prevention and treatment of STIs. |
Update to CDC's Treatment Guidelines for Gonococcal Infection, 2020
St Cyr S , Barbee L , Workowski KA , Bachmann LH , Pham C , Schlanger K , Torrone E , Weinstock H , Kersh EN , Thorpe P . MMWR Morb Mortal Wkly Rep 2020 69 (50) 1911-1916 Sexually transmitted infections (STIs) caused by the bacteria Neisseria gonorrhoeae (gonococcal infections) have increased 63% since 2014 and are a cause of sequelae including pelvic inflammatory disease, ectopic pregnancy, and infertility and can facilitate transmission of human immunodeficiency virus (HIV) (1,2). Effective treatment can prevent complications and transmission, but N. gonorrhoeae's ability to acquire antimicrobial resistance influences treatment recommendations and complicates control (3). In 2010, CDC recommended a single 250 mg intramuscular (IM) dose of ceftriaxone and a single 1 g oral dose of azithromycin for treatment of uncomplicated gonococcal infections of the cervix, urethra, and rectum as a strategy for preventing ceftriaxone resistance and treating possible coinfection with Chlamydia trachomatis (4). Increasing concern for antimicrobial stewardship and the potential impact of dual therapy on commensal organisms and concurrent pathogens (3), in conjunction with the continued low incidence of ceftriaxone resistance and the increased incidence of azithromycin resistance, has led to reevaluation of this recommendation. This report, which updates previous guidelines (5), recommends a single 500 mg IM dose of ceftriaxone for treatment of uncomplicated urogenital, anorectal, and pharyngeal gonorrhea. If chlamydial infection has not been excluded, concurrent treatment with doxycycline (100 mg orally twice a day for 7 days) is recommended. Continuing to monitor for emergence of ceftriaxone resistance through surveillance and health care providers' reporting of treatment failures is essential to ensuring continued efficacy of recommended regimens. |
Estimating recommended gonorrhea and chlamydia treatment rate using linked medical claims, prescription and laboratory data in US private settings
Tao G , Workowski K , Bowden KE , Pearson WS , Sullivan JM , Henk HJ , Gift TL . Sex Transm Dis 2020 48 (3) 167-173 BACKGROUND: The Centers for Disease Control and Prevention (CDC) recommends specific regimens for chlamydia and dual therapy for gonorrhea to mitigate antimicrobial resistant gonorrhea in the CDC 2015 STD Treatment Guidelines. Only limited studies examining adherence to these recommendations have been conducted at private practices in the United States. METHODS: We used the OptumLabs® Data Warehouse (OLDW), a comprehensive, longitudinal data asset with de-identified persons with linked commercial insurance claims and clinical information, to identify persons aged 15-60 years who had valid nucleic acid amplification testing results demonstrating urogenital or extragenital gonorrhea or chlamydia in 2016-2018. We defined valid lab results as positive or negative. We then assessed the time of their first positive test and the type of treatment within 30 days to determine if there was evidence in the claims record that the CDC-recommended treatment was provided. We defined presumed treatment if the date of treatment was before the date of the positive test within 30 days. RESULTS: Among 6,476 patients with positive gonorrhea tests and 26,847 patients with positive chlamydia tests only, 34.8% and 64.2% had evidence of receiving the CDC-recommended therapy, respectively. About 11.6% of patients with positive gonorrhea tests with recommended dual treatment and 7.1% of patients with positive chlamydia tests only with recommended chlamydia treatment were presumptively treated. CONCLUSION: Analysis of treatment claims and medical records from private settings indicated low rates of recommended gonorrhea and chlamydia treatment. Validation of treatment claims is needed to support further quality of care interventions based on these data. |
Optimising treatments for sexually transmitted infections: surveillance, pharmacokinetics and pharmacodynamics, therapeutic strategies, and molecular resistance prediction.
Sena AC , Bachmann L , Johnston C , Wi T , Workowski K , Hook EW 3rd , Hocking JS , Drusano G , Unemo M . Lancet Infect Dis 2020 20 (8) e181-e191 Progressive antimicrobial resistance in Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis has created a pressing need for treatment optimisations for sexually transmitted infections (STIs). In this Review, we aim to highlight urgent needs in global STI management, including: (1) improved surveillance to monitor antimicrobial resistance and clinical outcomes; (2) systematic pharmacokinetic and pharmacodynamic evaluations to ensure resistance suppression and bacterial eradication at all sites of infection; (3) development of novel, affordable antimicrobials; and (4) advancements in new molecular and point-of-care tests to detect antimicrobial resistance determinants. Antimicrobial resistance among STIs is a global public health crisis. Continuous efforts to develop novel antimicrobials will be essential, in addition to other public health interventions to reduce the global STI burden. Apart from prevention through safer sexual practices, the development of STI vaccines to prevent transmission is a crucial research priority. |
Evidence Review for Centers for Disease Control and Prevention Guidance Development on Laboratory Testing to Detect Treponema pallidum Infection (Syphilis).
Kersh EN , Workowski KA . Clin Infect Dis 2020 71 S1-s3 The articles in this supplement address key questions on syphilis diagnostics, provide reference tables of test performances, and discuss optimal specimens and knowledge gaps. Laboratory-developed genetic direct detection tests could be most useful at the point of care and add to the currently available serologic methods of nontreponemal and treponemal tests. |
Rationale for a Neisseria gonorrhoeae susceptible-only interpretive breakpoint for azithromycin
Kersh EN , Allen V , Ransom E , Schmerer M , Cyr S , Workowski K , Weinstock H , Patel J , Ferraro MJ . Clin Infect Dis 2020 70 (5) 798-804 BACKGROUND: Azithromycin (AZI) is recommended with ceftriaxone (CRO) for treatment of uncomplicated gonococcal urethritis and cervicitis in the United States, and an AZI-susceptibility breakpoint is needed. Neither the Food and Drug Administration (FDA) nor the Clinical and Laboratory Standards Institute (CLSI) has set interpretive breakpoints for AZI susceptibility. As a result, AZI antimicrobial susceptibility testing (AST) cannot be interpreted using recognized standards. This has contributed to increasingly unavailable clinical laboratory AST, although gonorrhea is on the rise with >550 000 US gonorrhea cases reported to the Centers for Disease Control and Prevention in 2017, the highest number of cases since 1991. METHODS: This article summarizes the rationale data reviewed by the CLSI in June 2018. RESULTS: The CLSI decided to set a susceptible-only interpretive breakpoint at the minimum inhibitory concentration of </=1 microg/mL. This is also the epidemiological cutoff value (ECV) (ie, the end of the wild-type susceptibility distribution). This breakpoint presumes that AZI (1-g single dose) is used in an approved regimen that includes an additional antimicrobial agent (ie, CRO 250 mg, intramuscular single dose). CONCLUSIONS: Having a breakpoint can improve patient care and surveillance and allow future development and FDA regulatory approval of modernized AST to guide treatment. The breakpoint coincides with a European Committee on AST decision to remove previously established, differing AZI breakpoints and use the ECV as guidance for testing. The CLSI breakpoint is now the recognized standard that defines AZI susceptibility for gonococcal infections. |
Evaluation of the National STD Curriculum: Reach, utilization, and engagement
Snoeyenbos Newman G , Bauer K , Karpenko A , Unruh KT , Johnston C , Marrazzo JM , Workowski KA , Spach DH . Sex Transm Dis 2020 47 (6) 412-418 BACKGROUND: With increasing rates of sexually transmitted infections (STIs) in the United States, there is a critical need to educate health professionals on the prevention, diagnosis, and treatment of STIs. The National STD Curriculum (NSTDC, https://www.std.uw.edu) is a free, online curriculum, funded by the Centers for Disease Control and Prevention (CDC). The purpose of this paper is to evaluate the reach, utilization, and engagement of users with the curriculum. METHODS: Data on NSTDC utilization was collected for 24 months after the February 1, 2017 launch. For all users, Google Analytics was used to determine total number of users, geographic location, age and sex, and average session duration. For registered users, additional data analysis included work-role, demographics, and completion of self-study modules, check-on-learning questions, and question banks. User satisfaction was measured on a 5-point Likert scale. RESULTS: During the evaluation period, 136,270 individual users accessed the NSTDC, including 24,652 registered users. Among all registered users, 10,660 (43.2%) were registered nurses, 2,810 (11.4%) physicians, 4,942 (20.1%) Advanced Practice Nurses and Physician Assistants, and 6,213 (25.2%) non-clinicians. Among registered users, 18,533 (75.2%) completed at least 1 module, 7,898 (32.0%) completed all 7 modules, and 19,804 (80.4%) answered optional check-on-learning questions. Median satisfaction with the content was (5) Very Satisfied (IQR 4-5). CONCLUSIONS: The NSTDC is a free, guideline-based, online curriculum with novel dual-functionality that has achieved extensive reach with a broad array of health professionals who engage deeply with the material. The wide usage of NSTDC demonstrates the need for high-quality, unbiased, free content in user-focused formats. |
Recommendations for providing quality sexually transmitted diseases clinical services, 2020
Barrow RY , Ahmed F , Bolan GA , Workowski KA . MMWR Recomm Rep 2020 68 (5) 1-20 This report (hereafter referred to as STD QCS) provides CDC recommendations to U.S. health care providers regarding quality clinical services for sexually transmitted diseases (STDs) for primary care and STD specialty care settings. These recommendations complement CDC's Sexually Transmitted Diseases Treatment Guidelines, 2015 (hereafter referred to as the STD Guidelines), a comprehensive, evidence-based reference for prevention, diagnosis, and treatment of STDs. STD QCS differs from the STD Guidelines by specifying operational determinants of quality services in different types of clinical settings, describing on-site treatment and partner services, and indicating when STD-related conditions should be managed through consultation with or referral to a specialist. These recommendations might also help in the development of clinic-level policies (e.g., standing orders, express visits, specimen panels, and reflex testing) that can facilitate implementation of the STD Guidelines. CDC organized the recommendations for STD QCS into eight sections: 1) sexual history and physical examination, 2) prevention, 3) screening, 4) partner services, 5) evaluation of STD-related conditions, 6) laboratory, 7) treatment, and 8) referral to a specialist for complex STD or STD-related conditions.CDC developed the recommendations by synthesizing relevant, evidence-based guidelines and recommendations issued by other experts; reviewing current practice in the United States; soliciting Delphi ratings by subject matter experts on STD care in primary care and STD specialty care settings; discussing the scientific evidence supporting the proposed recommendations at a consultation meeting of experts and institutional stakeholders held November 20, 2015, in Atlanta, Georgia; conducting peer reviews of draft recommendations and supporting evidence; and discussing draft recommendations and supporting evidence during meetings of the CDC/Health Resources and Services Administration Advisory Committee on HIV, Viral Hepatitis, and STD Prevention and Treatment STD Work Group. These recommendations are intended to help health care providers in primary care or STD specialty care settings offer STD services at their clinical settings and to help the persons seeking care live safer, healthier lives by preventing and treating STDs and related complications. |
Successful isolation of Treponema pallidum strains from patients' cryopreserved ulcer exudate using the rabbit model.
Pereira LE , Katz SS , Sun Y , Mills P , Taylor W , Atkins P , Thurlow CM , Chi KH , Danavall D , Cook N , Ahmed T , Debra A , Philip S , Cohen S , Workowski KA , Kersh E , Fakile Y , Chen CY , Pillay A . PLoS One 2020 15 (1) e0227769 Clinical isolates of Treponema pallidum subspecies pallidum (T. pallidum) would facilitate study of prevalent strains. We describe the first successful rabbit propagation of T. pallidum from cryopreserved ulcer specimens. Fresh ulcer exudates were collected and cryopreserved with consent from syphilis-diagnosed patients (N = 8). Each of eight age-matched adult male rabbits were later inoculated with a thawed specimen, with two rabbits receiving 1.3 ml intratesticularly (IT), and six receiving 0.6 ml intravenously (IV) and IT. Monitoring of serology, blood PCR and orchitis showed that T. pallidum grew in 2/8 rabbits that were inoculated IV and IT with either a penile primary lesion specimen (CDC-SF003) or a perianal secondary lesion specimen (CDC-SF007). Rabbit CDC-SF003 was seroreactive by T. pallidum Particle Agglutination (TP-PA) and Rapid Plasma Reagin (RPR) testing, PCR+, and showed orchitis by week 6. Euthanasia was performed in week 7, with treponemal growth in the testes confirmed and quantified by qPCR and darkfield microscopy (DF). Serial passage of the extract in a second age-matched rabbit also yielded treponemes. Similarly, rabbit CDC-SF007 showed negligible orchitis, but was seroreactive and PCR+ by week 4 and euthanized in week 6 to yield T. pallidum, which was further propagated by second passage. Using the 4-component molecular typing system for syphilis, 3 propagated strains (CDC-SF003, CDC-SF007, CDC-SF008) were typed as 14d9f, 14d9g, and 14d10c, respectively. All 3 isolates including strain CDC-SF011, which was not successfully propagated, had the A2058G mutation associated with azithromycin resistance. Our results show that immediate cryopreservation of syphilitic ulcer exudate can maintain T. pallidum viability for rabbit propagation. |
Hepatitis C Guidance 2019 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection
Ghany MG , Marks KM , Morgan TR , Wyles DL , Aronsohn AI , Bhattacharya D , Broder T , Falade-Nwulia OO , Feld JJ , Gordon SC , Heller T , Jhaveri RR , Jonas MM , Kiser JJ , Linas BP , Lo Re V , Peters MG , Reddy KR , Reynolds A , Scott JD , Searson G , Spradling P , Terrault NA , Trooskin SB , Verna EC , Wong JB , Woolley AE , Workowski KA . Hepatology 2019 71 (2) 686-721 The American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) initiated the hepatitis C guidance project (hereafter HCV guidance) in 2013. The AASLD-IDSA HCV guidance website (www.HCVGuidelines.org) disseminates up-to-date, peer-reviewed, unbiased, evidence-based recommendations to aid clinicians making decisions regarding the testing, management, and treatment of hepatitis C virus (HCV) infection. Utilizing a web-based system enables timely and nimble distribution of the HCV guidance, which is periodically updated in near real time as necessitated by emerging research data, recommendations from public health agencies, the availability of new therapeutic agents, or other significant developments affecting the rapidly evolving hepatitis C arena. |
Orolabial lymphogranuloma venereum, Michigan, USA
Ilyas S , Richmond D , Burns G , Bowden KE , Workowski K , Kersh EN , Chandrasekar PH . Emerg Infect Dis 2019 25 (11) 2112-2114 Orolabial lymphogranuloma venereum was diagnosed for a man in Michigan, USA, who had sex with men, some infected with HIV. High index of suspicion for lymphogranuloma venereum led to accurate diagnosis, successful therapy, and description of an L2b variant with a unique genetic mutation. |
Optimizing coverage vs frequency for sexually transmitted infection screening of men who have sex with men
Weiss KM , Jones JS , Anderson EJ , Gift T , Chesson H , Bernstein K , Workowski K , Tuite A , Rosenberg ES , Sullivan PS , Jenness SM . Open Forum Infect Dis 2019 6 (10) ofz405 Background: The incidence of bacterial sexually transmitted infections (STIs) in men who have sex with men (MSM) has increased substantially despite availability of effective antibiotics. The US Centers for Disease Control and Prevention (CDC) recommends annual screening for all sexually active (SA) MSM and more frequent screening for high-risk (HR) MSM. The population-level benefits of improved coverage vs increased frequency of STI screening among SA vs HR MSM are unknown. Methods: We used a network transmission model of gonorrhea (NG) and chlamydia (CT) among MSM to simulate the implementation of STI screening across different scenarios, starting with the CDC guidelines at current coverage levels. Counterfactual model scenarios varied screening coverage and frequency for SA MSM and HR MSM (MSM with multiple recent partners). We estimated infections averted and the number needed to screen to prevent 1 new infection. Results: Compared with current recommendations, increasing the frequency of screening to biannually for all SA MSM and adding some HR screening could avert 72% of NG and 78% of CT infections over 10 years. Biannual screening of 30% of HR MSM at empirical coverage levels for annual SA screening could avert 76% of NG and 84% of CT infections. Other scenarios, including higher coverage among SA MSM and increasing frequency for HR MSM, averted fewer infections but did so at a lower number needed to screen. Conclusions: The optimal screening scenarios in this model to reduce STI incidence among MSM included more frequent screening for all sexually active MSM and higher coverage of screening for HR men with multiple partners. |
Epidemiological impact of expedited partner therapy for men who have sex with men: A modeling study
Weiss KM , Jones JS , Katz DA , Gift TL , Bernstein K , Workowski K , Rosenberg ES , Jenness SM . Sex Transm Dis 2019 46 (11) 697-705 BACKGROUND: Expedited partner therapy (EPT) is an intervention for patients with gonorrhea or chlamydia, providing index patients with prescriptions or medication to give to their partners. Expedited partner therapy is recommended for heterosexuals but not for men who have sex with men (MSM), partially due to concerns about overtreatment of uninfected partners and missed opportunities for human immunodeficiency virus (HIV) diagnosis. METHODS: We extended our stochastic network-based mathematical model of HIV, gonorrhea, and chlamydia among MSM to include EPT. The EPT implementation was simulated for 10 years. Counterfactual scenarios varied EPT coverage, provision, uptake, and partnership window duration. We estimated sexually transmitted infection (STI) incidence, proportion of infections averted, and process outcomes under each scenario. RESULTS: Delivery of EPT to 20% of eligible MSM index patients (coverage) reduced cumulative STI incidence by 27% (interquartile range, 13%-39%) over 10 years compared with current estimated STI screening levels. A 20% increase in providing medication to non-index partners (provision) averted 32% (interquartile range, 20%-41%) of STI infections compared with estimated STI screening levels. When targeted by partnership type, EPT solely to casual partners maximized the population-level infections averted. The proportion of partners given medication who had no current STI varied from 52% to 63%, depending on coverage level. The proportion of partners given medication with undiagnosed HIV infection was 4% across scenarios. CONCLUSIONS: Expedited partner therapy could reduce bacterial STI incidence for MSM. However, this intervention could result in missed opportunities for HIV/STI prevention and a substantial increase in use of antimicrobials by STI-uninfected MSM, raising concerns about cost and antimicrobial resistance. |
Gentamicin as an alternative treatment for gonorrhoea
Kirkcaldy RD , Workowski KA . Lancet 2019 393 (10190) 2474-2475 A high gonorrhoea disease burden, increasing rates, and growing antimicrobial resistance portend a developing global public health crisis.1 Gonorrhoea can cause reproductive complications such as pelvic inflammatory disease and infertility, blindness in infants born to infected mothers, and can facilitate HIV acquisition and transmission. Effective treatment prevents sequelae and transmission. Yet Neisseria gonorrhoeae has developed resistance to each antimicrobial used for treatment.2 Development of new antimicrobials has not kept pace. |
Survey of obstetrician-gynecologists in the United States about trichomoniasis, 2016
Liu EW , Workowski KA , Taouk L , Schulkin J , Secor WE , Jones JL . Sex Transm Dis 2018 46 (1) 9-17 PURPOSE: Trichomoniasis is the most prevalent non-viral sexually transmitted infection in the United States. It can present with vaginitis in women and urethritis in men, but is most often asymptomatic or occurs with minimal symptoms. It is associated with other sexually transmitted infections (STIs), adverse pregnancy outcomes and pelvic inflammatory disease. For these reasons, healthcare provider awareness of trichomoniasis is of public health importance. METHODS: To assess practitioner knowledge, attitudes, and practices concerning trichomoniasis management, the American College of Obstetricians and Gynecologists (ACOG) conducted an online survey in 2016 of its members, and we analyzed results from 230 respondents. RESULTS: We note discrepancies between practice and recommendations amongst surveyed providers: a minority of respondents routinely screen HIV positive patients for trichomoniasis (10.7% "most of the time" 95% confidence interval [CI]: 6.7-15.8, 33.0% "always" 95% CI: 26.5%-40.0%), treat trichomoniasis in HIV positive patients with the recommended dose of metronidazole 500 mg twice a day for 7 days (25.8% 95% CI: 20.0%-32.3%), or retest patients diagnosed with trichomoniasis 3 months after treatment (9.6% 95% CI: 6.1%-14.3R). Only 29.0% (95% CI: 23.0%-35.5%) retreat with metronidazole 500 mg twice a day for 7 days in patients who have failed prior treatment. CONCLUSIONS: Screening for and treatment of trichomoniasis in HIV positive patients, as well as retesting and retreatment for trichomoniasis in the general population appear to be suboptimal. Continuing education for providers is needed for this common but "neglected" STI. |
Adherence to CDC Recommendations for the Treatment of Uncomplicated Gonorrhea - STD Surveillance Network, United States, 2016
Weston EJ , Workowski K , Torrone E , Weinstock H , Stenger MR . MMWR Morb Mortal Wkly Rep 2018 67 (16) 473-476 Gonorrhea, the sexually transmitted disease (STD) caused by Neisseria gonorrhoeae, is the second most common notifiable disease in the United States after chlamydia; 468,514 cases were reported to state and local health departments in 2016, an increase of 18.5% from 2015 (1). N. gonorrhoeae has progressively developed resistance to most antimicrobials used to treat the infection (2). As a result, CDC recommends two antimicrobials (250 mg of ceftriaxone [IM] plus 1 g of azithromycin [PO]) for treating uncomplicated gonorrhea to improve treatment efficacy and, potentially, to slow the emergence and spread of antimicrobial resistance. To monitor adherence to the current CDC-recommended regimen for uncomplicated gonorrhea, CDC reviewed enhanced data collected on a random sample of reported cases of gonorrhea in seven jurisdictions participating in the STD Surveillance Network (SSuN) and estimated the proportion of patients who received the CDC-recommended regimen for uncomplicated gonorrhea, by patient characteristics and diagnosing facility type. In 2016, the majority of reported patients with gonorrhea (81%) received the recommended regimen. There were no differences in the proportion of patients receiving the recommended regimen by age or race/ethnicity; however, patients diagnosed with gonorrhea in STD (91%) or family planning/reproductive health (94%) clinics were more likely to receive this regimen than were patients diagnosed in other provider settings (80%). These data document high provider adherence to CDC gonorrhea treatment recommendations in specialty STD clinics, indicating high quality of care provided in those settings. Local and state health departments should monitor adherence with recommendations in their jurisdictions and consider implementing interventions to improve provider and patient compliance with gonorrhea treatment recommendations where indicated. |
Dual antimicrobial therapy for gonorrhoea: what is the role of azithromycin
Unemo M , Workowski K . Lancet Infect Dis 2018 18 (5) 486-488 Antimicrobial resistance in Neisseria gonorrhoeae compromises the treatment of gonorrhoea globally.1,2 After the reports of the first gonococcal strains with highlevel resistance to ceftriaxone, the last remaining option for empirical gonorrhoea monotherapy, dual antimicrobial therapy (mainly ceftriaxone plus azithromycin) was implemented as the first-line treatment for uncomplicated gonorrhoea in many countries.2–7 Azithromycin resistance is described in many countries, which might threaten this dual therapy in the longer term. However, high-level azithromycin-resistant (HL-AziR) gonococcal isolates (minimum inhibitory concentration [MIC] ≥256 mg/L) have mainly been sporadically identified. |
Diagnostic importance of hyphae on heart valve tissue in Histoplasma endocarditis and treatment with isavuconazole
Wiley Z , Woodworth MH , Jacob JT , Lockhart SR , Rouphael NG , Gullett JC , Guarner J , Workowski K . Open Forum Infect Dis 2017 4 (4) ofx241 A patient who never resided in an endemic area for dimorphic fungi was diagnosed with Histoplasma capsulatum endocarditis. His diagnosis was suggested by yeast and hyphae on cardiac valve tissue pathology. Isavuconazole was an optimal therapeutic option due to renal dysfunction and anticoagulation with warfarin for mechanical valve replacement. |
Developing a public health response to Mycoplasma genitalium
Golden MR , Workowski KA , Bolan G . J Infect Dis 2017 216 S420-s426 Although Mycoplasma genitalium is increasingly recognized as a sexually transmitted pathogen, at present there is no defined public health response to this relatively newly identified sexually transmitted infection. Currently available data are insufficient to justify routinely screening any defined population for M. genitalium infection. More effective therapies, data on acceptability of screening and its impact on clinical outcomes, and better information on the natural history of infection will likely be required before the value of potential screening programs can be adequately assessed. Insofar as diagnostic tests are available or become available in the near future, clinicians and public health agencies should consider integrating M. genitalium testing into the management of persons with sexually transmitted infection (STI) syndromes associated with the infection (ie urethritis, cervicitis, and pelvic inflammatory disease) and their sex partners. Antimicrobial-resistant M. genitalium is a significant problem and may require clinicians and public health authorities to reconsider the management of STI syndromes in an effort to prevent the emergence of ever more resistant M. genitalium infections. |
Estimation of state-level prevalence of hepatitis C virus infection, US states and District of Columbia, 2010
Rosenberg ES , Hall EW , Sullivan PS , Sanchez TH , Workowski KA , Ward JW , Holtzman D . Clin Infect Dis 2017 64 (11) 1573-1581 Background.: Hepatitis C virus (HCV) infection is the most common chronic blood-borne infection in the United States and a leading cause of morbidity and mortality. Previous analyses of the US National Health and Nutrition Examination Survey (NHANES) indicated approximately 3.6 million noninstitutionalized persons with antibody to HCV (anti-HCV). However, state-level prevalence remains less understood and cannot be estimated reliably from NHANES alone. Methods.: We used 3 publicly available government data sources to estimate anti-HCV prevalence in each US state among noninstitutionalized persons aged ≥18 years. A small-area estimation model combined indirect standardization of NHANES-based prevalence with logistic regression modeling of mortality data, listing acute or chronic HCV infection as a cause of death, from the National Vital Statistics System during 1999-2012. Model results were combined with US Census population sizes to estimate total number and prevalence of persons with antibody to HCV in 2010. Results.: National anti-HCV prevalence was 1.67% (95% confidence interval [CI], 1.53-1.90), or 3 911 800 (95% CI, 3 589 400- 4 447 500) adults in 2010. State-specific prevalence ranged from 0.71% (Illinois) to 3.34% (Oklahoma). The West census region had the highest region-specific prevalence (2.14% [95% CI, 1.96-2.48]); 10 of 13 states had rates above the national average. The South had the highest number of persons with anti-HCV (n = 1561600 [95% CI, 1 427 700-1 768 900]). The Midwest had the lowest region-specific prevalence (1.14% [95% CI, 1.04%-1.30%]). Conclusions.: States in the US West and South have been most impacted by hepatitis C. Estimates of HCV infection burden are essential to guide policy and programs to optimally prevent, detect, and cure infection. |
Factors associated with primary care physician knowledge of the recommended regimen for treating gonorrhea
Bornstein M , Ahmed F , Barrow R , Risley JF , Simmons S , Workowski KA . Sex Transm Dis 2016 44 (1) 13-16 BACKGROUND: The recommended regimen for treating uncomplicated gonorrhea has changed over time, due to the emergence of antimicrobial resistance. We assessed physician knowledge of the recommendation for treating uncomplicated urogenital gonorrhea in adolescents and adults using ceftriaxone and azithromycin dual therapy. METHODS: We analyzed DocStyles 2015 survey data from 1357 primary care physicians practicing for at least 3 years who provided screening, diagnosis, or treatment for sexually transmitted diseases to one or more patients in an average month. Logistic regression and chi analyses were used to identify factors associated with knowledge of dual therapy. RESULTS: Among the options of treatment with ceftriaxone alone, azithromycin alone, both of these, or spectinomycin plus levofloxacin, 64% of physicians correctly preferred ceftriaxone plus azithromycin. Knowledge of the recommended dual therapy decreased with increasing years of practice, ranging from 74% among physicians with 3-9 years of practice to 57% among those practicing for ≥24 years (adjusted odds ratio, ORa, for ≥24 vs 3-9 years of practice, 0.50; 95% confidence interval [CI], 0.35-0.70). Knowledge of dual therapy decreased with higher socioeconomic status of patients (ORa for high income vs poor/lower middle income patients, 0.47; 95% CI, 0.32-0.69). Physicians who pursued continuing medical education using journals, podcasts, and government health agencies were more likely to report dual therapy than those who did not use these sources (ORa, 2.09; 95% CI, 1.31-3.33). CONCLUSIONS: Knowledge of the recommended regimen for treating gonorrhea decreased with increasing years of practice and with higher socioeconomic status of patients. |
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